0 Evaluaciones

ID

13430

Descripción

Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Palabras clave

  1. 8/2/16 8/2/16 -
  2. 11/2/16 11/2/16 -
Subido en

11 de febrero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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    SacBo PZ: Case Report Form Hospitalization Readmission DRKS00000084 NCT01143272

    SacBo PZ: Case Report Form Hospitalization Readmission NCT01143272

    Readmission
    Descripción

    Readmission

    When was the patient readmitted to the hospital?
    Descripción

    Hospital readmission date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0600290 (Hospital Readmissions)
    SNOMED
    417005
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Was the patient readmitted as an out-patient or as an in-patient?
    Descripción

    Readmission/return assessment. Please enter the medication obligatory for documentation in the "patient diary after discharge/transferal" AND in the data base. Please enter all other pages in the data base (except for patient diary) as well.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3844773 (Readmission/return assessment)
    LOINC
    LA10899-5
    What was the reason for the return/readmission to the hospital?
    Descripción

    Reason for return/readmission

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3844773 (Readmission/return assessment)
    LOINC
    LA10899-5
    What phase of the study is the patient currently in?
    Descripción

    Study phase

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)

    Similar models

    SacBo PZ: Case Report Form Hospitalization Readmission NCT01143272

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Readmission
    Hospital readmission
    Item
    When was the patient readmitted to the hospital?
    date
    C0600290 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Was the patient readmitted as an out-patient or as an in-patient?
    integer
    C3844773 (UMLS CUI [1])
    Code List
    Was the patient readmitted as an out-patient or as an in-patient?
    CL Item
    out-patient (1)
    CL Item
    in-patient (2)
    Item
    What was the reason for the return/readmission to the hospital?
    integer
    C3844773 (UMLS CUI [1])
    Code List
    What was the reason for the return/readmission to the hospital?
    CL Item
    Diarrhea/AAD/CDAD (1)
    CL Item
    Aggravation of underlying disease (2)
    CL Item
    Known and listed side effect of the antibiotic used (3)
    CL Item
    Adverse event (4)
    CL Item
    other reason (5)
    Item
    What phase of the study is the patient currently in?
    integer
    C2348568 (UMLS CUI [1])
    Code List
    What phase of the study is the patient currently in?
    CL Item
    Treatment 1 (1)
    CL Item
    Treatment 2 (2)
    CL Item
    Follow Up (3)

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